Manager, Regulatory Submission Project Management

The Manager of Regulatory Submission Project Management will be responsible for project management of submission deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). We expect them to manage other team members in Regulatory Submission Project Management, and provide support and backup to management as needed.

In this role, a typical day might include the following:

·       Provides oversight of therapeutic area(s) by guiding other team members who are responsible for INDs, CTAs, BLAs, sBLAs and MAAs and variations in that therapeutic area

·       Provides guidance to other team members and cross-functional groups to resolve issues related to timelines, submission documents or other regulatory-related matters that could impact the timeliness or quality of submissions

·       Provides input and proposals on standardizing submission management work, including processes and activities related to use of the regulatory document management system, functionality of the regulatory document management system and how specific document types are managed in the system. This includes activities related to programs that involve partnerships that may involve additional complexities due to documents being exchanged across companies.

·       Provides oversight on routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces and protocol amendments

·       Manages submission activities related to pre-IND or Scientific Advice submissions, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, BLA annual reports and Investigator Brochures (IBs)

This role might be for you if you have:

• 5+ years relevant experience.
• A bachelor’s degree.
• Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). 
• eCTD knowledge.
• Project management skills. 
• Working knowledge with MS Office applications and Adobe Acrobat.
• Working knowledge of MS Project and electronic document management systems (eg, SharePoint). 

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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